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- The study must be reviewed by an independent data monitor.
- The results of Mentor's breast implants will be reviewed by FDA in five years to verify that implants are performing as expected.
Silicone-gel breast implants began selling in 1962 and were banned in 1992 amid health fears. Research since then has shown that they do not cause serious diseases like cancer or lupus but that they can cause infection and scar tissue if they leak and are untreated.
Approximately 264,000 breast enlargements and 63,000 breast reconstructions were performed in United States in 2003 - vast majority using salt water filled implants that are sold without restriction. It is estimated that if silicone breast implants return to market, 200,000 women may have them installed within first year.
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Allen Jenks is a freelance writer that writes for The Nutrition Guide at http://www.thenutritionguide.com and My Attorney Finder http://www.myattorneyfinder.com.